LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) has introduced the aPAP ClearPath Dried Blood Spot (DBS) Test in the United States, offering a groundbreaking solution for diagnosing autoimmune pulmonary alveolar proteinosis (aPAP), a rare lung disease. The test requires just a finger-prick blood sample and builds upon the serum-based assay previously launched by the company.
Demonstrating 100% analytical sensitivity and specificity, the DBS test ensures accuracy by correlating GM-CSF autoantibody levels in dried blood samples with traditional serum samples. This innovation provides a reliable and noninvasive diagnostic option, eliminating the need for venous blood draws. Development and validation were conducted in partnership with TrilliumBiO, a CLIA-certified health solutions lab, ensuring adherence to rigorous quality standards.
“I’m pleased to see that Savara has continued to evolve aPAP ClearPath and is now offering a dried blood spot version that provides a convenient alternative to traditional venous blood draws,” said Ali Ataya, M.D., Associate Professor of Medicine at the University of Florida. “Having a simplified and reliable diagnostic reduces logistical barriers for both patients and healthcare providers and may help physicians diagnose aPAP earlier, as well as avoid common and lengthy misdiagnoses associated with the disease.”
Savara’s CEO and Chair, Matt Pauls, emphasized the company’s commitment to addressing the unmet needs in aPAP care. “We are happy to introduce a version of aPAP ClearPath that can provide physicians with a tool to help confirm or rule out aPAP with just a few drops of blood,” he said. “As we near the completion of our rolling BLA submission for MOLBREEVI™ in aPAP, which is on track for the end of 1Q 2025, we are steadfastly committed to our goal of providing the aPAP community with the first and only approved treatment option in the U.S.”
The launch of the DBS test marks a significant step forward in diagnostic accessibility, offering a faster and more patient-friendly approach to identifying aPAP. This advancement reflects Savara’s broader mission to innovate rare disease therapeutics and improve outcomes for patients.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.